Transcription of Standards: Medical Devices
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Standards: Medical Devices
Taylor, A. Page 1 Standards: Medical Devices Medical Devices are subject to strict general controls and procedural regulations. The development and use of standards is vital to ensuring the safety and efficacy of Medical Devices . Numerous regulatory agencies and standards organizations collaborate to establish the accepted standards for Medical equipment. Standard setting activities include the development of performance characteristics, characterization and testing methodologies, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labeling, or other technical or policy criteria.
Compatibility (IEC 60601‐1‐2) or Protection for diagnostic use of X‐rays (IEC 60601‐1‐3). In recent years, consideration of the environmental impact of the device has also been added. This standard asks manufacturers of medical devices to consider the
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